Nearly 30,000 neonatal and pediatric children worldwide undergo Extracorporeal Life Support (ECLS) each year. Unfortunately, their doctors currently cannot objectively determine when a child's heart and lungs are strong enough to safely wean from life support. Transonic proposes to meet this need by developing the first non-invasive device that can measure cardiac output at the end of the surgery requiring cardiopulmonary bypass, and at the conclusion of Veno-Arterial Extracorporeal Membrane Oxygenation (VA ECMO). It will also be able to measure the catheter recirculation during Veno-Venous (VV) ECMO, which subsequently allows the calculation of mixed venous oxygen saturation. The proposed device relies on existing disposable tubing connected to existing ECLS cannulas. The measurements are made by injecting small amounts of isotonic saline into the extracorporeal tubing. Ultrasonic flowsensors clamped onto the extracorporeal tubing measure flow and saline dilution over time. The resulting saline indicator dilution curves allow calculation of recirculation, mixed venous oxygen saturation, and cardiac output. This configuration eliminates the need for further surgical invasion and ensures that the measurement procedure is safe, quick, accurate, and inexpensive. These measurements could improve the efficacy of therapy and could reduce the average US$120,800/patient cost of ECLS treatment. The Phase-I bench, animal, and clinical studies demonstrated the feasibility of this measurement approach. The proposed Phase-II program will build from this success, and will design, build, and test improved clamp-on flowsensors, robust software, and a stand-alone touch-screen monitor. The improved devices will undergo bench and animal testing prior to clinical studies at four ECLS/ECMO centers. The Phase-II clinical studies will form the basis for a Phase-III FDA clearance and manufacturing authorization. The resulting pediatric ECLS monitor would reduce pediatric morbidity/mortality and the associated health care costs, and would be marketable worldwide in every pediatric hospital that performs heart surgery and/or that has an ECLS program. PUBLIC HEALTH RELEVANCE: Each year nearly 30,000 children worldwide undergo Extra-Corporeal Life Support (ECLS) each year, at an average cost of US$120,800 per patient and total costs of US$3.6 Billion/year. While the treatments can save lives, doctors currently cannot objectively determine when a child's heart and lungs are strong enough to safely remove life support. The proposed technology will provide doctors with a new non-invasive device to measure a child's heart/lung function during and after ECLS, which may lead to better treatments, shorter hospital stays, and significantly reduced treatment costs. [unreadable] [unreadable] [unreadable]